Toronto, Ontario – December 17, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that Health Canada has approved its next generation anti-cancer drug, TLD-1433, under Clinical Trial Application (“CTA”) for evaluation in a Phase Ib clinical trial for patients inflicted with Non-Muscle Invasive Bladder Cancer (“NMIBC”).
Health Canada recently reviewed the CTA submitted by the Company and has issued a “No Objection Letter” stating that Health Canada has no objection to the proposed Phase Ib clinical study, a standard response, allowing the Company to proceed with enrolling patients who meet the inclusion and exclusion criteria of the study pending Health Canada Investigational Testing Authorization (“ITA”) of the TLC-3200 medical laser system used to activate TLD-1433 in the bladder and University Health Network Review Ethics Board (“UHN REB”) approval of the clinical protocol.
Roger Dumoulin-White, President and CEO, stated that, “The Company has focused its resources on the successful completion of four major strategic objectives prior to yearend; specifically:
• Health Canada approval of the next generation TLC-2000 Therapeutic Medical Laser System (completed)
• FDA approval of the TLC-2000 (completed)
• Health Canada CTA approval (completed) and Health Canada ITA approval (pending)
• UHN REB approval (pending)
Theralase has now completed the first 2.5 of these four strategic objectives and is working hard to complete the remaining objectives prior to yearend.
The CTA approval by Health Canada represents many years of hard work by Theralase’s dedicated employees and the professional consultants that have worked tirelessly to achieve this goal. We are all extremely proud of this accomplishment and look forward to proving the main study objectives of safety and tolerability of our next generation anti-cancer technology, but also the exploratory objective of efficacy in a patient population inflicted with this deadly disease.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology Division designs, manufactures and markets patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy Division researches and develops specially designed molecules called Photo Dynamic Compounds, which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
Additional information is available at theralase.com and sedar.com.
Theralase Technologies Inc. was recognized as a TSX Venture 50® company in 2015. TSX Venture 50 is a trademark of TSX Inc. and is used under license.
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com